NEEDLE BIOPSY DEVICE WITH EXCHANGEABLE NEEDLE AND INTEGRATED NEEDLE PROTECTION
The invention provides a device for needle biopsy having a novel delivery handle system for interchangeably delivering needles of various sizes to a biopsy site. The delivery handle system is adjustable in length and includes a proximal handle member slideably disposed over a middle handle member, and the middle handle member is slideably disposed over a distal handle member. The proximal handle member includes an inner hub housing component configured to interchangeably receive a needle subassembly that can be inserting into and withdrawn from the proximal handle member. The needle subassembly includes a needle of a plurality of different sizes, a needle luer, a needle hub coupled to a proximal end portion of the needle, and a needle protector subassembly. The needle protector subassembly includes a needle protection hub configured to receive the distal end of a needle.
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This patent application is a continuation-in-part of U.S. Ser. No. 13/029,593 filed Feb. 17, 2011, which claims priority to U.S. Ser. No. 61/305,304, filed Feb. 17, 2010, and U.S. Ser. No. 61/305,396 filed Feb. 17, 2010; is a continuation-in-part of U.S. Ser. No. 12/607,636, filed Oct. 28, 2009, which claims priority to U.S. Ser. No. 61/117,966, filed Nov. 26, 2008, and U.S. Ser. No. 61/152,741, filed Feb. 16, 2009; is a continuation-in-part of U.S. Ser. No. 12/243,367, filed Oct. 1, 2008. The entire contents of each of the above-mentioned applications are incorporated by reference herein.
TECHNICAL FIELDThe present disclosure generally relates to the biopsy devices, and more particularly, needle biopsy devices for collecting tissue, fluid, and cell samples in conjunction with procedures such as endoscopic ultrasound or endoscopic bronchial ultrasound.
BACKGROUND INFORMATIONEndoscopic ultrasounds have been used for more than twenty five years within the field of medicine. These procedures allow clinicians to scan, locate and identify individual layers of the gastrointestinal (GI) tract and determine the location of individual mucosal and submucosal layers. As a result, appropriate therapeutic modes of treatment for malignancies and various abnormalities may be determined.
Endoscopic Ultrasound-Guided Fine-Needle Aspiration (“EUS-FNA”) and Endobronchial Ultrasound-Guided Fine-Needle Aspiration (“EBUS-FNA”) are currently standard modes of treatment in the field of GI Endoscopy and Bronchoscopy with high yields of sensitivity and specificity in the management of indications/diseases such as esophageal cancer, pancreatic cancer, liver mass, non-small cell lung cancer, pancreatic mass, endobronchial mass, and intra-abdominal lymph nodes.
A typical endoscopic ultrasound procedure consist of several steps. First, a clinician sedates a patient and inserts a probe via esophagogastroduodenoscopy into the patient's stomach and duodenum. Second, an endoscope is passed through the patient's mouth and advanced to the level of the duodenum. Third, from various positions between the esophagus and duodenum, organs or masses outside the gastrointestinal tract are imaged to determine abnormalities. If any abnormalities that are present, the organs and/or masses can be biopsied through the process of “fine needle aspiration” (FNA).
Endoscopic ultrasounds and endoscopic bronchial ultrasounds through fine needle aspiration are presently the standard modes of diagnosis and/or treatment in the field of gastrointestinal endoscopy and bronchoscopy. These procedures traditionally result in high yields of sensitivity and specificity in the management of indications of diseases such as esophageal cancer, pancreatic cancer, liver mass, non-small cell lung cancer, pancreatic mass, endobronchial mass, and intra-abdominal lymph nodes.
An endoscopic ultrasound through fine needle aspiration requires a device that is attached to the luer port or working channel of a typical echoendoscope. Prior art devices utilize a series of push and pull handles to control the axial movement of the catheter shaft of the device and the depth of needle penetration. These devices, however, suffer from several drawbacks.
One primary drawback of current FNA devices, concerns the lack of “Needle Safe Preventative” design features which protect the end user from inadvertent needle penetration and the transfer of blood-borne pathogens from patient subject to attending medical staff (Ref: The Needle-stick Safety and Prevention Act (HR 5178)—OSHA Regulation).
One of the primary issues still facing the medial device industry concerns the propensity for “Needle Stick”. The Occupational Health and Safety Administration (OSHA) has warned that most needle destruction devices (NDDs) are “not compliant” with the Bloodborne Pathogens Standard, which are defined as “ . . . controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protection and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.” To comply with the OSHA standard, an employer must use engineering and work practice controls that will “eliminate or minimize employee exposure” (OSHA Sec. 1910.1030(d)(2)(i)). OSHA's compliance directive explains that under this requirement “the employer must use engineering and work practice controls that eliminate occupational exposure or reduce it to the lowest feasible extent” (OSHA CPL 2-2.69 §XIII, D.2.). The employer's exposure control plan is to describe the method the employer will use to meet the regulatory requirement. The plan must be reviewed and updated at least annually to reflect changes in technology that will eliminate or reduce exposure (Sec. 1910.1030(c)(1)(iv)).
In the case of currently available FNA medical devices for both EUS and EBUS, once the sample has been aspirated from the desired anatomical location, the FNA catheter is removed from the echoendoscope and handed to the cytopathologist for sample extraction/preparation. The user is instructed to “re-sheath” the needle (i.e. retract the needle into the catheter sheath) prior to detachment from the echoendoscope.
However, in many instances, this does not occur. As such, the needle sharp of the device is exposed during removal and transfer of the FNA device among medical staff in the EUS/EBUS suite with increased risk of “needle sticking” and blood borne pathogen contamination/exposure to same.
Therefore, a need exists for an improved device for use in endoscopic ultrasound procedures which address the lack of adherence to OSHA HR 5178, of current EUS and EBUS Fine Needle Aspiration devices.
Additionally, prior FNA devices in the art are not designed to individually accommodate needles of various diameters. Prior art fine needle aspiration device design used in the field of endoscopic ultrasound sample acquisition, are designed such that the sampling needle is fully integrated into the handle drive mechanism of the device. Specifically, in the case of prior art devices, the full system needle biopsy device (handle and integrated needle) must be removed from an endoscope during a procedure if a clinician chooses to utilize needles of different sizes. In this instance, the sample aspirate is removed from the needle of the device with an en-suite cytopathologist. The removal and prepping of the aspirated sample is time consuming and results in significant wait-time for the clinician between needle biopsy system passes and sampling.
Another drawback of current FNA devices known in the art is that if the same needle biopsy system (as in the case of the prior art) is used throughout a procedure for sampling at numerous anatomical locations, the durability of both the needle and the stylette components of the device frequently become compromised (i.e. the needle and/or stylette components may take a “shape-set”, kink or fracture). This results in a prolonging of the procedure for the clinician, hospital staff and prolonged periods of sedation for the patient with a reduction in overall procedural efficiency.
In this instance, the clinician must remove the needle biopsy system from the endoscope; open a second new device of different needle size; re-insert the new device into the endoscope and re-confirm position of the endoscope and needle relative to the intended sampling site, before acquiring the sample. In many instances, the device may be un-useable after successive needle passes. In this instance, no alternative exists for the clinician but to utilize a new device for the remainder of the procedure.
A further drawback of prior art fine needle biopsy devices used in endoscopic and endobronchial ultrasound procedures concerns the lack of flexibility provided to the clinician during a procedure.
Current EUS-FNA needle biopsy systems are commercially available in needle sizes of 19, 22 and 25 gauge, with integrated handle and needle embodiments. In many instances the endoscopist or pulmonologist may desire to utilize a different size needle during a procedure. For example, a clinician may begin an endoscopic ultrasound or endobronchial ultrasound procedure with: (1) a device having a needle biopsy system with a diameter of 19 AWG; (2) aspirate the sample; (3) remove the needle biopsy system from the endoscope; (4) attach and lock a new needle biopsy device (for example, 22 AWG size) to the endoscope and continue the procedure. This results in a loss of procedural efficiency for the clinician, patient and hospital and also increases procedural costs through the utilization of a second, new needle biopsy device.
Therefore, a need exists for an improved device for use in endoscopic ultrasound and endobronchial procedures which increases procedural efficiency, reduces procedural costs and improves procedural economics.
SUMMARY OF THE INVENTIONThe invention provides a device for needle biopsy that includes a novel for a delivery handle system for interchangeably delivering needles of various sizes to a biopsy site. The delivery handle system has an adjustable length, a longitudinal axis defining a lumen extending therethrough, and includes a proximal handle member, a middle handle member and a distal handle member. The proximal handle member is slideably disposed over at least a portion of the middle handle member, the middle handle member is slideably disposed over at least a portion of the distal handle member. The proximal handle member includes an inner hub housing component having an internally cylindrical shape configured to interchangeably receive a needle subassembly that can be inserted into and withdrawn from the proximal handle member.
The needle subassembly for insertion into and withdrawal from the delivery handle system includes an aspiration needle of a plurality of different sizes, each needle having a proximal end portion and a distal end portion. Preferably, the aspiration needle ranges in size from a 15 AWG to a 28 AWG aspiration needle (e.g., 19 AWG, 22 AWG or 25 AWG). A needle luer and a needle hub are coupled to the proximal end portion of the needle, the needle hub being configured for coupling with the inner hub housing component of the proximal handle member. The needle subassembly further includes a needle protector subassembly configured for coupling to the distal end portion of the needle. The needle protector subassembly includes a needle protection hub having a lumen extending therethrough configured for receiving the distal end portion of the needle, a deformable O-ring axially disposed within the lumen of the needle protection hub, and a tubular sheath defining a lumen extending from a distal end of the needle protection hub. The lumen of the tubular sheath is in communication with the lumen of the needle protection hub for receiving the needle when inserted into the needle protection hub. In one embodiment of the invention, the tubular sheath distally extending from the needle protector subassembly includes an internally tapering distal end.
In a preferred embodiment, the aspiration needle of the needle subassembly includes a collet surrounding the distal end portion of the needle. The collet has a diameter larger than the diameter of the deformable O-ring of the needle protection hub, such that the collet traverses the deformable O-ring when the needle is inserted into or withdrawn from the lumen of the needle protection hub, thereby locking the needle protector subassembly onto the distal end portion of the needle during insertion and withdrawal of the needle subassembly from the delivery handle system. The collet preferably chamfered at the proximal and distal ends to provide a smooth interface with the needle protector subassembly during needle exchange.
The aspiration needle of the needle subassembly also preferably includes a distal tip having four distinct angular bevel grinds, including a primary angle relative to the needle shaft, a secondary angle relative to the needle shaft, and a back-cut angle relative to the secondary angle for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure.
The lumen extending through the delivery handle system includes an inner hypotube component at least partially disposed within the proximal handle member and an outer hypotube component disposed at least partially within the middle handle member. The inner hypotube is coupled to the outer hypotube and configured to longitudinally slide within the outer hypotube when the proximal handle member is distally advanced or proximally retracted over the middle handle member. The lumen further includes a tubular catheter sheath coupled to a distal end of the outer hypotube. The inner hypotube, outer hypotube and catheter sheath are in constant communication with each other.
Preferably, the catheter sheath includes a helically braided reinforcement structure and has an outer diameter ranging from 0.05 inches to 0.140 inches, and an inner diameter ranging from 0.05 inches to 0.120 inches. In certain embodiments, the catheter sheath includes a tapered distal tip having an outer and inner diameter that is smaller than the outer and inner diameters of the remaining length of the catheter sheath. In certain embodiments, the inner diameter of the distal tip ranges from 0.020 inches to 0.060 inches.
The delivery handle system of the invention further includes an inner handle member disposed within an inner portion of the middle handle member. The inner handle member is coupled to a proximal portion of the catheter sheath and a distal portion of the outer hypotube, such that the catheter sheath is distally extended into the distal handle member when the middle handle member is distally advanced over the distal handle member.
The delivery handle system of the invention further includes a first locking mechanism configured to prevent the proximal handle member from longitudinally sliding over the middle handle member, and a second locking mechanism configured to prevent the middle handle member from longitudinally sliding over the distal handle member. The first locking mechanism includes a first ring slideably disposed around at least a portion of the middle handle member. A screw is threaded within the first ring for locking the first ring in a fixed position along the middle handle member. The second locking mechanism includes a threaded insert disposed along a distal portion of the middle handle member. The threaded insert is coupled to a screw for tightening the threaded insert to lock middle handle member in a fixed position along the distal handle member.
The proximal handle member of the delivery handle system of the invention includes an inner retention collar disposed at a distal end of the inner hub housing component. The inner retention collar is configured to receive the needle protection hub coupled to the needle. At least a portion of the retention collar is recessed, and the deformable O-ring component is disposed within the recessed portion for securing the needle protection hub within the retention collar upon insertion of the needle subassembly into the proximal handle member.
In certain embodiments, the O-ring of the retention collar has a diameter smaller than a diameter of the needle protection hub, such that the needle protection hub traverses the deformable retention collar O-ring when the needle subassembly is inserted into or withdrawn from the proximal handle member thereby locking the needle protector subassembly onto the proximal handle portion during insertion and withdrawal of the needle subassembly from delivery handle system.
The proximal handle member further includes a locking mechanism for releasably locking the needle hub within the inner hub housing component of the proximal handle member. The locking mechanism includes a depressible latch component securely coupled to the proximal handle member. The latch includes a deflectable hinge coupled to a barb component, that is coupled to the inner hub housing component and disposed within an interior portion of the proximal handle member.
The needle hub of the needle subassembly includes an internal land ring for interacting with the deflectable hinge and barb component of the locking mechanism. The internal land ring traverses the deflectable hinge of the latch component when the needle subassembly is inserted into the lumen of the proximal handle member, thereby causing the deflectable hinge to deflect against the barb component during insertion. The deflectable hinge returns to a home position once the internal land ring has cleared the deflectable hinge to prevent the needle hub from moving backwards. The needle subassembly is released from the inner hub housing component of the proximal handle member by depressing the latching component to cause the deflectable hinge to deflect against the barb component to allow the internal land ring to clear the deflectable hinge and barb.
In certain embodiments, the inner hub housing component of the proximal handle member includes a plurality of depressions spaced around an internal circumference of the hub housing component and the needle hub comprises a plurality of protrusions. The plurality of depressions are configured to receive the plurality of protrusions to prevent the needle hub from rotating relative to the hub housing component. Alternatively, the inner hub housing component includes a smooth internal circumference and the needle hub comprises a smooth outer surface to allow the needle hub rotate relative to the hub housing component.
In certain embodiments, the delivery handle system of the invention includes a luer holder coupled to a distal end of the distal handle member for coupling the distal handle member to a working channel port of an endoscope. In such embodiments, the luer holder includes a luer lock for locking the distal handle member in a fixed position relative to the working channel of the endoscope to prevent the delivery handle system from rotating about the working channel.
These and other aspects of the invention are described in further detail in the figures, description, and claims that follow.
In the following description, various embodiments of the present invention are described with reference to the following drawings that illustrate exemplary embodiments of the invention. Together with the description, the drawings serve to explain the principles of the invention. In the drawings, like structures are referred to by like numerals throughout the several views. Note that the illustrations in the figures are representative only, and are not drawn to scale, the emphasis having instead been generally placed upon illustrating the principles of the invention and the disclosed embodiments.
The invention provides a device for needle biopsy for collecting tissue, fluid, and cell samples in conjunction with procedures such as an endoscopic ultrasound (EUS) or endoscopic bronchial ultrasound (EBUS).
An exemplary embodiment of the proposed device assembly is illustrated in
The delivery system handle 10 incorporates two length adjustment features actuated via adjustment of two thumbscrew locking mechanisms. A threaded proximal thumbscrew 12 and locking ring 33 are moveably disposed around the middle handle member 10b; the proximal thumbscrew 12 is loosened to loosen locking ring 33, locking ring 33 is moved distally along the middle handle member 10b and tightened in the desired position along middle handle member 10b via proximal thumbscrew 12 to allow the user to establish a set depth of needle penetration beyond the end of the catheter sheath 14. A threaded distal thumbscrew 13 is transversely disposed at the distal portion of the middle handle member 10b; the distal thumbscrew 13 is loosened to move the middle handle member 10b distally and/or proximally and tightened to allow the user to establish a set depth of catheter sheath 14 extension beyond the end of the endoscope.
The needle sub-assembly 15 consists of the needle shaft 21 (which can range in length from 500 mm up to 2500 mm, but which more preferably ranges in length between 1640 mm to 1680 mm) and is beveled at the distal needle end to enhance tissue penetration during sample acquisition; needle hub 17; needle luer 18; needle collet 19; needle protector sub-assembly 9; stylette hub 20 and stylette shaft 22. The needle component itself can be manufactured from a number of metallic based (Stainless steel or alloys thereof; Nitinol or Alloys thereof etc. . . . ) or Polymeric Based materials including, but not limited to Poly-ether-ether ketone, Polyamide, Poyethersulfone, Polyurethane, Ether block amide copolymers, Polyacetal, Polytetrafluoroethylene and/or derivatives thereof).
The aspiration needle sub-assembly 15 also incorporates a needle collet 19 (previously described as “needle protrusion(s) and shown in FIGS. 3 and 10 of Applicant's co-pending application (U.S. Ser. No. 12/243,367, published as US2010/0081965). The function of this needle collet 19 is to (1) provide a means to center the needle shaft component in the catheter sheath of the delivery system during needle exchange (2) provide a mechanism or securing and locking the needle protector sub-assembly to the distal end of the aspiration needle once the needle has been unlocked and withdrawn from the delivery system handle. The needle collet 19 of the present invention may be attached to the distal end of the needle shaft 21 via a number of processing techniques such as adhesive bonding, laser welding, resistance welding, or insert injection molding. The needle collet 19 may be fabricated from metals materials such as stainless steel, nickel titanium or alloys thereof or polymer materials such as, but not limited to, Polyacetal, polyamide, poly-ether-block-amide, polystyrene, Acrylonitrile butadiene styrene or derivatives thereof. The needle collet 19 is located at a set point distance from the extreme distal end of the beveled needle. The distance from the extreme distal end of the needle bevel to the proximal collet position on the needle may be within the range of 6 cm to 12 cm but is more preferably in the range of 7 cm to 9 cm and more preferably is located 8 cm from the end of the needle. This ensures that when the needle is extended to it's maximum extension distance relative to the distal end of the catheter sheath (i.e. 8 cm), the collet 19 does not exit the end of catheter sheath 14.
The needle hub 17 embodiment of the aspiration needle sub-assembly as shown in
An alternate preferred embodiment of the proximal end of the aspiration needle sub-assembly 15 is shown in
Referring to FIGS. 5.a and 5.b, thumb latch 28 and external coupler housing 28b may be manufactured from a range of rigid, non-deformable, thermoplastic or thermoset materials such as, acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), polystyrene or rigid derivatives thereof, polyamide, polyethylene, polyurethane, and polycarbonate. In an embodiment, the materials of manufacture have a durometer in the range of 35-120 Shore D, but more preferably in the range of 80-110 Shore D.
Hinge member 28a may be manufactured from a range of rigid, thermoplastic or thermoset materials such as, acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), polystyrene or rigid derivatives thereof, polyamide, polyethylene, polyurethane, and polycarbonate. In an embodiment, the materials of manufacture shall be capable of deformation in bending under the application of an applied load, such as is encountered during a typical “Open and Close” cycle for the needle biopsy device without crazing, fatigue or cracking.
The proximal portion of the proximal handle member 10a of the delivery system handle 10, incorporates a retention collar 29 and a retention collar O-ring component 30. The retention collar component 29 resides in a cut out nest in the proximal handle half, and is in communication with inner hub housing component 27. The retention collar 29 is a cylindrical component, which is internally tapered and recessed to provide an internal, recessed shelf. The retention collar O-ring component 30 resides in this recessed shelf and is secured in position through the assembly of both halves of the delivery system handle halves. The purpose of this retention O-Ring component 30 is to provide a method to lock and maintain the needle protector hub sub-assembly 9 of the aspiration needle sub-assembly 15, securely in the handle 10 of the delivery system while the tissue sample site is being accessed by the clinician, as described in detail below. The functionality and operation of this retention collar O-Ring component 30 is the same as described in
As shown in
Referring now to
As shown in
Referring to
As depicted in
In certain aspects of the invention, the echogenically enhanced region of the needle is achieved through the removal of material from the surface of the needle to provide greater reflectivity and strengthened reflected signal. It is contemplated that the removal of material does not, however, reduce the performance of the needle from a pushability perspective or deter its ability to acquire a desired sample.
Referring now to
Referring now to
Referring now to
During needle exchange, it is important that the aspiration needle (with pre-loaded stylette 2) can be passed through the internal diameter of the catheter sheath 14 without catching on the internal wall of same. In order to achieve this, the bevel grind of the current invention incorporates a back-cut grind detail. This back-cut detail acts as a “bumper” during needle passage through the sheath. As the needle advances, the heel of the back-cut comes in contact with the internal diameter of the sheath and reduces the friction between needle end 35 and catheter sheath 14 components. In this way, the needle can be smoothly tracked through the catheter sheath to exit the end of the catheter sheath 14.
An intended functionality of thumb latch 28 is to prevent the aspiration needle subassembly 15 from being removed from the proximal handle member 10a without applying force to release thumb latch 28. As shown in
During aspiration needle exchange, and more specifically during needle insertion, the needle collet component 19 disengages from the NP Hub O-ring 25 by traversing the NP Hub O-ring 25 as explained above.
In the case of the present invention, the needle protector sheath 24 is internally tapered 24a at the distal end (
In the case of the present invention, the catheter shaft component 14 is manufactured from a thermoplastic polymer such as, but not limited to Polyurethane, Polyamide and derivatives thereof, Ether block amide copolymers, Polyimide, Placental, Polyethylene and derivatives thereof, Poly-tetrafluoroethylene. The preferred embodiment of the catheter shaft 14 (as shown in
In the case of the present invention (and as illustrated in
Referring now to
Certain embodiments according to the invention have been disclosed. These embodiments are illustrative of, and not limiting on, the invention. Other embodiments, as well as various modifications and combinations of the disclosed embodiments, are possible and within the scope of the disclosure.
Claims
1. A device for needle biopsy comprising:
- a delivery handle system having an adjustable length, a longitudinal axis defining a lumen extending therethrough, and comprising a proximal handle member, a middle handle member and a distal handle member, the proximal handle member being slideably disposed over at least a portion of the middle handle member, the middle handle member being slideably disposed over at least a portion of the distal handle member, the proximal handle member comprising an inner hub housing component comprising an internally cylindrical shape configured to interchangeably receive a needle subassembly configured for inserting into and withdrawing from the proximal handle member;
- the needle subassembly comprising a needle of a plurality of different sizes, each needle having a proximal end portion and a distal end portion, a needle luer coupled to the proximal end portion of the needle, and a needle hub coupled to the proximal end portion of the needle, the needle hub configured for coupling with the inner hub housing component of the proximal handle member;
- the needle subassembly further comprising a needle protector subassembly configured for coupling to the distal end portion of the needle, the needle protector subassembly comprising a needle protection hub having a lumen extending therethrough configured for receiving the distal end portion of the needle, a deformable O-ring axially disposed within the lumen of the needle protection hub, and a tubular sheath defining a lumen extending from a distal end of the needle protection hub, the lumen of the tubular sheath in communication with the lumen of the needle protection hub for receiving the needle when inserted into the needle protection hub.
2. The device of claim 1, wherein the lumen extending through the delivery handle system comprises:
- an inner hypotube component at least partially disposed within the proximal handle member;
- an outer hypotube component disposed at least partially within the middle handle member, the inner hypotube being coupled to the outer hypotube and configured to longitudinally slide within the outer hypotube when the proximal handle member is distally advanced or proximally retracted over the middle handle member; and
- a tubular catheter sheath coupled to a distal end of the outer hypotube,
- the inner hypotube, outer hypotube and catheter sheath being in constant communication with each other.
3. The device of claim 2, further comprising an inner handle member disposed within an inner portion of the middle handle member, the inner handle member coupled to a proximal portion of the catheter sheath and a distal portion of the outer hypotube, such that the catheter sheath is distally extended into the distal handle member when the middle handle member is distally advanced over the distal handle member
4. The device of claim 1, further comprising:
- a first locking mechanism configured to prevent the proximal handle member from longitudinally sliding over the middle handle member; and
- a second locking mechanism configured to prevent the middle handle member from longitudinally sliding over the distal handle member.
5. The device of claim 4, wherein the first locking mechanism comprises a first ring slidably disposed around at least a portion of the middle handle member, and a screw threaded within the first ring for locking the first ring in a fixed position along the middle handle member, and the second locking mechanism comprises a threaded insert disposed along a distal portion of the middle handle member, the threaded insert coupled to a screw for tightening the threaded insert to lock middle handle member in a fixed position along the distal handle member.
6. The device of claim 1, wherein the needle subassembly comprises an aspiration needle ranging from 15 AWG to 28 in size.
7. The device of claim 1, wherein the needle further comprises a collet surrounding the distal end portion of the needle, the collet comprising a diameter larger than the diameter of the deformable O-ring of the needle protection hub, such that the collet traverses the deformable O-ring when the needle is inserted into or withdrawn from the lumen of the needle protection hub, thereby locking the needle protector subassembly onto the distal end portion of the needle during insertion and withdrawal of the needle subassembly from the delivery handle system.
8. The device of claim 7, wherein the collet is chamfered at a proximal end and a distal end of the collet to provide a smooth interface with the needle protector subassembly during needle exchange.
9. The device of claim 1, wherein the proximal handle member further comprises an inner retention collar disposed at a distal end of the inner hub housing component, the inner retention collar configured to receive the needle protection hub coupled to the needle, at least a portion of the retention collar being recessed, and a deformable O-ring component disposed within the recessed portion for securing the needle protection hub within the retention collar upon insertion of the needle subassembly into the proximal handle member.
10. The device of claim 9, wherein the O-ring of the retention collar has a diameter smaller than a diameter of the needle protection hub, such that the needle protection hub traverses the deformable retention collar O-ring when the needle subassembly is inserted into or withdrawn from the proximal handle member thereby locking the needle protector subassembly onto the proximal handle portion during insertion and withdrawal of the needle subassembly from delivery handle system.
11. The device of claim 1, wherein the proximal handle member further comprises a locking mechanism for releasably locking the needle hub within the inner hub housing component of the proximal handle member.
12. The device of claim 11, wherein the locking mechanism comprises a depressible latch component securely coupled to the proximal handle member, the latch comprising a deflectable hinge coupled to a barb component, the barb component coupled to the inner hub housing component, disposed within an interior portion of the proximal handle member.
13. The device of claim 12, wherein the needle hub of the needle subassembly further comprises an internal land ring for interacting with the deflectable hinge and barb component of the locking mechanism, whereby the internal land ring traverses the deflectable hinge of the latch component when the needle subassembly is inserted into the lumen of the proximal handle member, thereby causing the deflectable hinge to deflect against the barb component during insertion, the deflectable hinge returning to a home position once the internal land ring has cleared the deflectable hinge to prevent the needle hub from moving backwards, and whereby the needle subassembly is released from the inner hub housing component of the proximal handle member by depressing the latching component to cause the deflectable hinge to deflect against the barb component to allow the internal land ring to clear the deflectable hinge and barb.
14. The device of claim 1, wherein the inner hub housing component comprises a plurality of depressions spaced around an internal circumference of the hub housing component and the needle hub comprises a plurality of protrusions, the plurality of depressions configured to receive the plurality of protrusions to prevent the needle hub from rotating relative to the hub housing component.
15. The device of claim 1, wherein the inner hub housing component comprises a smooth internal circumference and the needle hub comprises a smooth outer surface to allow the needle hub rotate relative to the hub housing component.
16. The device of claim 1, wherein the needle comprises a distal tip having four distinct angular bevel grinds.
17. The device of claim 16, wherein the four angular bevel grinds comprise a primary angle relative to the needle shaft, a secondary angle relative to the needle shaft, and a back-cut angle relative to the secondary angle for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure, and enhanced echogenicity or acoustic reflection of the distal tip of the needle.
18. The device of claim 1, wherein the tubular sheath distally extending from the needle protector subassembly comprises an internally tapering distal end.
19. The device of claim 2, wherein the catheter sheath comprises an outer diameter ranging from 0.05 inches to 0.140 inches, and an inner diameter ranging from 0.05 inches to 0.120 inches.
20. The device of claim 2, wherein the catheter sheath comprises a tapered distal tip comprising an outer and inner diameter that is smaller than the outer and inner diameters of the catheter sheath.
21. The device of claim 20, wherein the inner diameter of the distal tip ranges from 0.020 inches to 0.060 inches.
22. The device of claim 2, wherein the catheter sheath comprises a helically braided reinforcement structure.
23. device of claim 1, further comprising a luer holder coupled to a distal end of the distal handle member and configured for coupling the distal handle member to a working channel port of an endoscope.
24. The device of claim 23, wherein the luer holder comprises a luer lock for locking the distal handle member in a fixed position relative to the working channel of the endoscope to prevent the delivery handle system from rotating about the working channel.
25. A device for needle biopsy comprising:
- an adjustable delivery handle system, at least a portion of the delivery handle system comprising an inner lumen configured to interchangeably receive a needle subassembly; and
- a needle subassembly removably disposed within the inner lumen and comprising an interchangeable needle comprising a distal tip having four distinct angular bevel grinds.
26. The device of claim 25, wherein the four distinct angular bevel grinds comprise a primary angle relative to the needle shaft, a secondary angle relative to the needle shaft, and a back-cut angle relative to the secondary angle for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure, and enhanced echogenicity or acoustic reflection of the distal tip of the needle
Type: Application
Filed: Nov 16, 2011
Publication Date: May 10, 2012
Patent Grant number: 9332973
Applicant: Beacon Endoscopic Corporation (Danvers, MA)
Inventors: JOHN MCWEENEY (Brighton, MA), Micheal Kelly (Tubber)
Application Number: 13/297,766
International Classification: A61B 10/02 (20060101);